Removal of large bile duct stones can be technically challenging at ERCP. Particularly, when the size of the stone is more than 1.2cm they are removed using a metal basket (lithotripsy). This can sometimes be technically challenging and may require more than one ERCP session. Recently, a balloon has been used to enlarge the opening of the bile duct (sphincteroplasty) to help easy removal of stones in one ERCP session. There are no studies comparing the lithotripsy and sphincteroplasty techniques. This randomized trial is designed to address the question of which technique is superior for bile duct stone extraction: lithotripsy versus sphincteroplasty.

Compare technical success defined as the ability to clear the bile duct of all stones within 20 minutes in one ERCP session using either the sphincteroplasty or mechanical lithotripsy techniques. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Ability to clear the bile duct of all stones within 20 minutes in one ERCP session using mechanical lithotripsy.

Procedure: Mechanical Lithotripsy

Ability to clear the CBD of all stones using mechanical lithotripsy within 20 minutes following sphincterotomy.

Active Comparator: Balloon sphincteroplasty

Ability to clear the bile duct of all stones within 20 minutes in one ERCP session using balloon sphincteroplasty.

Procedure: Balloon Sphincteroplasty

Ability to clear the bile duct of all stones within 20 minutes in one ERCP session using balloon sphincteroplasty.

Detailed Description:

Stones in the bile duct can result in various complications including acute cholangitis, acute pancreatitis and secondary biliary cirrhosis.1 Bile duct stones should therefore be removed and this can be successfully achieved in 85-90% of patients using standard endoscopic techniques. This comprises endoscopic sphincterotomy whereby the duodenal sphincter at the entrance of the bile duct is cut during endoscopic retrograde cholangiopancreatography (ERCP) and subsequent removal of the stone is achieved using standard accessories such as a basket and/or extraction balloon.2 However, large (≥ 15mm in size) or multiple stones and those located in non-dilated bile ducts can be difficult to remove by endoscopic sphincterotomy and using only standard accessories.2 In such cases, mechanical lithotripsy can be performed for stone fragmentation prior to removal. This involves the use of a basket and a sheath that can be wrapped around the stone, which are in turn attached to a handle that is turned to result in stone fragmentation.1,2 Although shown to be effective in 84-98% of patients with large stones, this method can be cumbersome and time-consuming.2

Endoscopic Balloon sphincteroplasty (EBS) [(Hurricane RX Balloon Dilatation Catheter; Boston Scientific Corp., Natick, MA, USA) or CRE Wireguided Balloon Dilatation Catheter; Boston Scientific Corp., Natick, MA, USA)] is an alternative technique in which a balloon is used to dilate the papilla located at the bile duct opening by up to 8-20mm (depending on size of the distal CBD) after performing an endoscopic sphincterotomy. Following dilation, the stone is removed using a basket and/or extraction balloon. This technique was shown to be effective in clearing the bile duct in 89-95% of patients with difficult bile stones in whom initial endoscopic sphincterotomy was unsuccessful.3 Furthermore, in a randomized trial comparing endoscopic sphincterotomy alone versus EBS for removal of bile duct stones, the use of mechanical lithotripsy was significantly lower in the EBS group (28.8% for EBS vs. 46.2% for endoscopic sphincterotomy only, p=0.028), although the overall stone clearance rates were comparable between the two groups (89% for ESBD vs. 88.5% for ES only, p=0.279).4

The SpyGlass Direct Visualization System (Boston Scientific Corp., Natick, MA, USA) is a single-operator peroral cholangioscopy system (POC) which allows direct visualization of the bile duct stone.2 The main advantage of this technique is that a probe can be inserted into the endoscope and then guided through the bile duct to reach the stone. Using this probe, the energy from laser (laser lithotripsy) can be accurately focused onto the stone to cause stone fragmentation under direct visualization.1 The use of SpyGlass system with laser lithotripsy has been shown to be successful in the clearance of difficult bile duct stones in 73-100% patients.4-9

Although various methods for removal of bile duct stones exist, there have been thus far no studies directly comparing EBS with cholangioscopy-guided laser lithotripsy for clearance of bile duct stones. The aim of this study is therefore to compare efficiency of the single-operator peroral cholangioscopy-directed laser lithotripsy (POC-LL) using the SpyGlass Direct Visualization system versus EBS for clearance of difficult bile duct stones.

Eligibility

Ages Eligible for Study:

19 Years to 90 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age > 19 years,

Common bile duct stones that measure more than 1.2 cm at ERCP.

Exclusion Criteria:

Patients unable to provide informed consent due to any diminished capacity,

Pregnant patients or age < 19 years or prisoners,

Presence of bleeding disorders,

Patients with altered post-surgical anatomy.

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852072